mRNA-1345 Vaccine for Respiratory Syncytial Virus

Recruiting at 68 trial locations

Overseen By Moderna Clinical Trials Support Center

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: ModernaTX, Inc.

Must not be taking: mRNA vaccines

Disqualifiers: Anaphylaxis, Drug abuse, Fever, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 week

360 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that you should not receive any mRNA or COVID-19 vaccines within 4 weeks before or after the trial's start date, and no other vaccines within 2 weeks before or after.

What data supports the effectiveness of the mRNA-1345 treatment for Respiratory Syncytial Virus?

Research shows that the mRNA-1345 vaccine, which targets a specific protein of the RSV virus, has shown promising results in older adults by increasing the body's immune response to the virus. Additionally, mRNA vaccines, like those used for COVID-19, have been successful in generating strong immune responses, suggesting potential effectiveness for RSV as well. ^{1 2 3 4 5}

How is the mRNA-1345 drug different from other RSV treatments?

The mRNA-1345 drug is unique because it uses mRNA technology to encode a stabilized version of the RSV F protein, which helps the body produce a strong immune response against the virus. Unlike other treatments, it specifically targets the pre-fusion conformation of the RSV F protein, which is crucial for neutralizing the virus, and there are currently no standard vaccines available for RSV. ^{1 2 5 6 7}

What is the purpose of this trial?

This trial is testing a new vaccine called mRNA-1345 that aims to protect against a lung infection virus known as RSV. The study focuses on pregnant women and their newborns. The vaccine works by teaching the body to recognize and fight the virus using a small piece of genetic material. mRNA-1345 is among the most promising RSV vaccines currently being tested.

Eligibility Criteria

This trial is for pregnant women aged 18 to less than 40, who are between 28-36 weeks into their pregnancy. They must be able to attend all study visits and have had standard antenatal care. Infants born to these mothers can also participate with parental consent.

Inclusion Criteria

I plan to give birth where the study's procedures are available.

Pregnant participants have had a prenatal ultrasound at 18 weeks of pregnancy or are willing to have one if not already done.

I have been and plan to continue receiving standard pregnancy care.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Pregnant women receive a single intramuscular injection of mRNA-1345 or placebo between 28 to 36 weeks of gestation

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and immunogenicity, including pregnancy and birth outcomes

12 months postdelivery

Treatment Details

Interventions

• mRNA-1345

Trial Overview The trial is testing mRNA-1345, a new vaccine aimed at preventing respiratory syncytial virus (RSV). Pregnant women will receive either the vaccine or a placebo to assess safety and immune response in them and their newborns.

Participant Groups

Group I: mRNA-1345 Dose C Experimental Treatment 1 Intervention

Participants will be vaccinated in the period from 28 weeks to 36 weeks of gestation with a single IM injection of mRNA-1345 Dose C.

Group II: mRNA-1345 Dose B Experimental Treatment 1 Intervention

Participants will be vaccinated in the period from 28 weeks to 36 weeks of gestation with a single IM injection of mRNA-1345 Dose B.

Group III: mRNA-1345 Dose A Experimental Treatment 1 Intervention

Participants will be vaccinated in the period from 28 weeks to 36 weeks of gestation with a single intramuscular (IM) injection of mRNA-1345 Dose A.

Group IV: Placebo Placebo Group 1 Intervention

Participants will receive single IM injection of mRNA-1345 vaccine matching placebo in the period from 28 weeks to 36 weeks of gestation.

mRNA-1345 is already approved in United States for the following indications:

Approved in United States as mRESVIA for:

• Prevention of lower respiratory tract disease caused by RSV infection in adults aged 60 years and older

Who Is Running the Clinical Trial?

ModernaTX, Inc.

Lead Sponsor

Trials

127

Recruited

66,790,000+

Dr. Stephen Hoge

ModernaTX, Inc.

Chief Medical Officer

MD from Harvard Medical School

Stéphane Bancel

ModernaTX, Inc.

Chief Executive Officer since 2011

MBA from Harvard Business School, MSc in Engineering from École Centrale Paris

Findings from Research

The mRNA-1345 vaccine demonstrated high efficacy, with 83.7% effectiveness in preventing RSV-associated lower respiratory tract disease with at least two symptoms, and 68.4% efficacy against RSV-associated acute respiratory disease in a study involving 35,541 older adults.

The vaccine was generally safe, with most adverse reactions being mild to moderate and transient, although there was a higher incidence of local and systemic reactions compared to the placebo group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of an mRNA-Based RSV PreF Vaccine in Older Adults. Wilson, E., Goswami, J., Baqui, AH., et al.[2023]

The RSVPreF3 vaccine candidate was found to be safe for use in 213 healthy pregnant women, with no significant adverse events related to the vaccine or placebo reported during the study.

The vaccine effectively increased RSV-specific neutralizing antibody levels in mothers and successfully transferred these antibodies to newborns, indicating strong immunogenicity and potential protection for infants against RSV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Immunogenicity of an Investigational Respiratory Syncytial Virus Vaccine (RSVPreF3) in Mothers and Their Infants: A Phase 2 Randomized Trial. Bebia, Z., Reyes, O., Jeanfreau, R., et al.[2023]

The investigational RSV vaccine ChAd155-RSV was well-tolerated in healthy adults aged 18-45, with no dose-related toxicity or serious adverse events observed during a 1-year follow-up.

ChAd155-RSV effectively increased specific immune responses, including neutralizing antibodies and T-cell activity, indicating its potential efficacy in generating protection against RSV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-in-Human Randomized Study to Assess the Safety and Immunogenicity of an Investigational Respiratory Syncytial Virus (RSV) Vaccine Based on Chimpanzee-Adenovirus-155 Viral Vector-Expressing RSV Fusion, Nucleocapsid, and Antitermination Viral Proteins in Healthy Adults. Cicconi, P., Jones, C., Sarkar, E., et al.[2022]

Advancements in understanding the RSV surface fusion glycoprotein have led to the development of various vaccine approaches, including mRNA vaccines, which are currently showing promising results in clinical trials for preventing RSV in infants and the elderly.

The mRNA-1345 vaccine has received FDA fast-track designation for adults over 60, highlighting its potential as a safe and effective preventative measure against RSV, especially following the success of mRNA technology in COVID-19 vaccines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of mRNA vaccines against respiratory syncytial virus (RSV). Qiu, X., Xu, S., Lu, Y., et al.[2023]

The mRNA-based vaccine V172, designed to target the pre-fusion form of the RSV F glycoprotein, was found to be safe and well-tolerated in a Phase 1 clinical trial involving 112 older adults and 48 younger adults, with common side effects being mild and manageable.

V172 induced higher neutralizing antibody levels compared to a previous vaccine candidate (V171.2) and demonstrated protective effects in an animal model, suggesting it could be an effective option for preventing RSV infections in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a stabilized RSV pre-fusion F mRNA vaccine: Preclinical studies and Phase 1 clinical testing in healthy adults. Nussbaum, J., Cao, X., Railkar, RA., et al.[2023]

The Ad26.RSV.preF vaccine, tested in a phase 1/2a study with 352 adults aged 60 and older, was found to be well tolerated, showing similar side effects across different regimens.

Combining Ad26.RSV.preF with RSV preF protein significantly enhanced humoral immune responses while maintaining cellular responses, suggesting this combination could be more effective in generating immunity against RSV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, Immunogenicity, and Regimen Selection of Ad26.RSV.preF-based Vaccine Combinations: A Randomized, Double-blind, Placebo-Controlled, Phase 1/2a Study. Comeaux, CA., Bart, S., Bastian, AR., et al.[2023]

The investigational mRNA vaccine (mRNA-1777) targeting Respiratory Syncytial Virus (RSV) was found to be safe and well-tolerated in both younger (72 participants) and older adults (107 participants), with no serious adverse events reported.

The vaccine successfully triggered a strong immune response, indicated by increased levels of RSV neutralizing antibodies and other immune markers, suggesting its potential effectiveness in protecting against RSV infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase 1, randomized, placebo-controlled study to evaluate the safety and immunogenicity of an mRNA-based RSV prefusion F protein vaccine in healthy younger and older adults. Aliprantis, AO., Shaw, CA., Griffin, P., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of an mRNA-Based RSV PreF Vaccine in Older Adults. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Safety and Immunogenicity of an Investigational Respiratory Syncytial Virus Vaccine (RSVPreF3) in Mothers and Their Infants: A Phase 2 Randomized Trial. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

First-in-Human Randomized Study to Assess the Safety and Immunogenicity of an Investigational Respiratory Syncytial Virus (RSV) Vaccine Based on Chimpanzee-Adenovirus-155 Viral Vector-Expressing RSV Fusion, Nucleocapsid, and Antitermination Viral Proteins in Healthy Adults. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Development of mRNA vaccines against respiratory syncytial virus (RSV). [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Evaluation of a stabilized RSV pre-fusion F mRNA vaccine: Preclinical studies and Phase 1 clinical testing in healthy adults. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Safety, Immunogenicity, and Regimen Selection of Ad26.RSV.preF-based Vaccine Combinations: A Randomized, Double-blind, Placebo-Controlled, Phase 1/2a Study. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

A phase 1, randomized, placebo-controlled study to evaluate the safety and immunogenicity of an mRNA-based RSV prefusion F protein vaccine in healthy younger and older adults. [2021]